Roche

Roche’s drug candidate for Multiple Sclerosis touted to be better than Merck’s Rebif

The much anticipated multiple sclerosis drug from Roche, ocrelizumab, has overtaken Merck’s Rebif according to the results of Phase III data, and has also shown great stats that could prove that it might have an edge in the hotly contested market. If the candidate is approved, Ocrevus is expected to be a tough rival, given its data in progressive MS; no other MS drug has yet proven to be effective in those hard-to-treat patients, and that success is expected to help Ocrevus in the market as well.

The researchers from the Office of Prescription Drug Promotion and RTI International analyzed 65 sites for branded cancer meds, and found out that almost all of them cited specific numbers on their effectiveness and side effects- which is not enough. It has not come as a surprise as the regulations require disclosure of effectiveness as well as side effects. The FDA agency has also found that these sites list far more treatment benefits as compared to risks, and are seriously harming the patients by providing incomplete information.

The FDA norms likely to punch a Rs 5,000 crore hole in Indian Pharma Industry

The Compliance to the US Food and Drug Administration norms might turn out to be a costly affair for Indian Pharma companies. The main reflection of this is in the way legal and professional costs have surged for many companies, more than some’s annual revenues. For 135 listed pharma companies, this has jumped threefold to Rs 5,071 crore in past five years, based on their annual reports.

Takeda sets aside $15B for U.S. M&A deals

Takeda has shown a great shift in R&D philosophy after it set aside the major part of drug research and development responsibilities and took up other development deals in oncology, vaccines and CNS. Also, it has set aside close to $15 billion for M&A deals in the USA, to buy companies that fit in with the vision Takeda has for itself.

Therapeutics developed to create innovative medicines based on the use of new and improved antibodies is the next generation cure for the treatment of various diseases. In past decade, the antibody drug conjugates have emerged out as the active areas of many biopharmaceutical companies and contract manufacturing firms. With recent approvals of two ADC, Adcetris and Kadcyla and many in clinical pipeline, the ADC development has become one of the most attractive and exciting new class of drugs especially in oncology therapeutics. The present two ADC which are market have been approved by both US Food and Drug Administration (FDA) and the European Medicine Agency (EMA).

These antibody drug conjugates have increased selectivity and enhanced efficacy which attracts the developers with real promise and massive potential of becoming a huge hit as monoclonal antibodies itself. It is composed by linking an antibody with the cytotoxic drug. A good target selection, its internalization rate and optimization of each part plays a vital role. Although when it comes to efficacy a lot of research is been done into the targeting of the ADCs. The internalization also depends on the drug payload with novel mechanism of action. It is highly important to consider that if multiple toxins are used it can be either better or could lead to more resistance. Some of the promising payloads are Auristatin, Pyrrolobenzodiazapines (PBDs) and Maytinsinoid. The ADC development future is much dependent on the site specific conjugation as better site specific methods will lead to improved drug to antibody ratio and shelf life. Have a look at Top 5 Companies and their ADCs in pipeline

Technological advancements, success of monoclonal antibodies (MAb) and increasing demands of biologics drugs in globally for the treatment of chronic diseases are prime factors to drive this market. In October 2013, Roche announced that it plans to invest 800 million Swiss francs in global biologic medicine manufacturing network. The company is coming up with combination product with Kadcyla in clinical trials. With linker technology advances in antibody therapies, raise in healthcare expenditure and huge government initiatives, North America has the largest market for the next generation of antibody based therapeutics followed by Europe. With growing demographics and economics, demand of better healthcare facilities, increasing incidence of chronic diseases and growing R&D activities one can expect that Asia will also observe a high growth rate in coming years.

A trend frequently observed in ADC market is the increasing number of collaborations and partnerships particularly for the technology advantages and rise in number of mergers and acquisitions. MedImmune subsidiary of AstraZeneca are jointly developing two therapies with ADC Therapeutics. Spirogen are in partnership with ADC therapeutics for several oncology indications. Despite of increasing number of companies getting into collaboration, there are few top challenges identified in common such as optimization of multi-parameters, lack of proof of concept with right characteristics selection, scale up of processes, drug to antibody ratio, lack of regulatory guidance and high cost of research and development with further commercialization. ADC half life and drug stability are also important factors which depend on the better understanding of PK and related toxicity. With the upcoming of many ADC technologies under exploration, the challenges and competition are rising. Better communication networks and collaborations both internally in a company and externally will solve a number of issues as within a company itself different components of ADC are dealt with different departments. With many organizations looking forward to this exciting new class of drug, the major focus should lie in the early stage discovery and opportunities. Currently the major players in the market associated with ADCs are Seattle Genetics, MedImmune, F. Hoffmann-La Roche Ltd, ImmunoGen, Amgen and Pfizer. The contract manufacturing organizations also play vital role like Piramal, Lonza and SAFC invests for the production of ADC.

The industry’s 10 biggest-selling cancer drugs generated combined sales of $37.4billion in 2013, with Roche’s Rituxan, Avastin and Herceptin franchises extending their lead at the top of this league table. With combined sales of around $21 billion, these three drugs alone accounted for approximately 56 percent of the combined value of the 10 biggest-selling products.

Drug Name

Company

Rituxan/MabThera

Roche, Pharmstandard

Avastin

Roche

Herceptin

Roche

Gleevec

Novartis

Alimta

Eli Lilly

Velcade

Johnson & Johnson, Takeda,Pharmstandard

Erbitux

Merck KGaA, Bristol-Myers Squibb

Lupron, Eligard

AbbVie and Takeda; Sanofi and Astellas Pharma

Zytiga

Johnson & Johnson

Revlimid

Celgene, Pharmstandard

Rituxan is developed by Roche’s Genentech which is the first monoclonal antibody treatment for cancer. And even after 15 years on the market, it continues to see its sales grow, up 6% for Roche in 2013. The drug is also approved to treat a number of cancers, including non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (CLL), it also works against rheumatoid arthritis and generates about $1.2 billion a year in that category.

By comparing the sales of all the drugs the Roche company becomes the king of all the Pharmaceutical Companies involved in making oncology drugs.

Let’s have a look over the ranking on the basis of oncology sales 2013.

Roche has topped the ranking by its top selling drugs, followed by Amgen, Novartis, Celgene, Johnson and Johnson, Lily, Astrazeneca, Merck, BMS and Takeda.

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